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Lots of New ODAG/CDAG Guidance and Clarity

by Yvonne Tso, PharmD, MBA

On August 3, 2022, the Centers for Medicare & Medicaid Services (CMS) released an updated version of the Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance which is effective immediately[1]. For Sponsoring Organizations (Sponsors) preparing for their upcoming program audit in the 2022 cycle, the updates incorporating the new Dismissal regulations and other provisions in CMS-4190f1 and f2 are noteworthy. The August 2022 updated version also clarifies existing language in the guidance with respect to:

  • Plan Communications to Enrollee (Section 10.4.4)

  • When Notification is Considered Delivered by the Plan (Section 10.5.3)

  • Notification Requirements for Dismissal of coverage and appeal requests (Sections 20.2.1, 50.9.1)

  • Turnaround time for change in review priority (Section 40.8)

  • Criteria for Dismissal of an Initial Coverage Determination and Dismissal Notification (Section 40.15)

  • Non-contract providers’ appeal rights (Section 50.1.1)

Dismissals are no longer required for submission in a separate table (Table 13 in prior year’s protocol) in the 2022 program audit protocol. Instead, dismissed requests are reported in tables 1-3 for ODAG[2] and tables 1-4 in CDAG[3]. Whether the request was appropriately dismissed or whether it should have been treated as a coverage request or grievance falls under the audit element of Classification of Requests.

Plan Communications: Sponsors must ensure enrollees with limited English proficiency are able to communicate with plans regarding initial determinations, appeals, and grievances. CMS considers this to be part of building a culture of equity and quality improvement. Although Sponsors already have a 5% threshold translation requirement, Section 10.4.4 emphasizes that enrollees with limited English proficiency should have equal access to the above-mentioned processes as those with English proficiency.

Timeliness: For written notification, CMS has clarified that written notification is considered delivered on the date (and time, if applicable) the notice has been deposited into the courier drop box or external outgoing mail receptacle (e.g., U.S. Postal Service or FedEx bin) or, for electronic delivery of required materials, the date (and time, if applicable) the plan sends the materials to the enrollee. Sponsors’ mail room policies have been requested by CMS as part of the documentary reviews in program audits. A standard written policy and validation by the vendor, if mailing notification is delegated to a third party, should be available to ensure and evidence timeliness. Verbal notification or a voicemail message can buy three calendar days for notification; absent either, the written notification must be mailed out within the applicable timeframe. For Part C reconsiderations, subsequent to verbal notification of determination, the written notification has to be mailed out within the applicable timeframe (30 days from receipt of the request) or 7 calendar days from the date of receipt for Part D standard redeterminations or as expeditiously as the enrollee's health condition requires. With the CMS Timeliness Monitoring Project (TMP[4]) pending, Sponsors should make sure their written notification procedures are compliant.

Dismissal Criteria and Processes: Sponsors must send a written dismissal notice to the enrollee (or other proper party) as well as to the person asserting representative status if the dismissal is due to a missing or defective representative form. Requirements for the content of the dismissal notice are detailed in Section 20.2.1. Sponsors may have to re-program their current dismissal notice if the content is not meeting the requirements.

Sponsors must dismiss a request for an initial determination when a) the requestor is not eligible or permissible to make the request, b) if the request is not valid (namely, the method and place for filing a request are incorrect or requesting a tiering exception for an approved non-formulary Part D drug), c) the request is pending when the enrollee passes and there is no party/entity remaining with a financial interest in the case, or d) the requestor has withdrawn the request timely. When the request has been timely withdrawn, the Sponsor is required to dismiss the initial determination request and issue a dismissal notice to preserve the rights of other proper parties to the decision who may wish to request review of the dismissal (Section 40.15.1). There is more guidance for dismissals in the new version (Section 50.9) with which Sponsors’ staff should be familiar.

Non-contract provider (NCP) appeal rights: These include partial payments for services rendered due to down-coding by the payer, level of care or rate of payment denials, or denial of procedure codes. To protect the enrollee, any appeals for reconsideration of payment by an NCP have to be filed with a signed Waiver of Liability, absence of which has been cited as a condition in program audits.

Review priority change does not allow extra review time; i.e., if the remaining standard review period is less than the applicable expedited review period, the original standard deadline still applies.

If there are questions about the revisions or guidance in the newly released document, feel free to contact Integritas Medicare at 415-596-5277.

[1] An Addendum to the Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance for Applicable Integrated Plans was published in December 2020, effective 1/1/2021 [2] ODAG= Part C Organization Determinations, Appeals and Grievances [3] CDAG= Part D Coverage Determinations, Appeals and Grievances [4] TMP = Timeliness Monitoring Project announced on April 5, 2022 to begin in September 2022

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